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Published by capintec, 2018-02-19 20:29:34

CAPTUS 4000e Manual

CAPTUS 4000e Manual

CAPTUS® 4000e

Manual Stock No. 9250-0151 August, 22 2017
Rev. G 2017/08/22

THYROID UPTAKE SYSTEM
OWNER’S MANUAL

Capintec, Inc.
7 Vreeland Road
Florham Park, NJ 07932 USA
Phone (800) ASK-4CRC
Fax (201) 825-1336

The authorized representative located within the Community is:
Atlantico Systems Ltd.

34 Oldfield, Kingston, Galway, Republic of Ireland

Copyright© 2015 Capintec, Inc.

CAPTUS® is a registered trademark of Capintec, Inc.

ALL RIGHTS RESERVED



CAPINTEC, INC. CAPTUS® 4000e

TABLE OF CONTENTS

PREFACE

SAFETY ............................................................................................................................. 1-1
GENERAL....................................................................................................................... 1-1
SYMBOL DEFINITIONS ................................................................................................. 1-1
WARNING AND CAUTION LABELS............................................................................... 1-2
CAUTIONS AND NOTES................................................................................................ 1-3
GENERAL SAFETY TIPS ............................................................................................... 1-6

FUNCTIONAL & TECHNICAL DESCRIPTION .................................................................. 2-1
INTENDED USE ............................................................................................................. 2-1
OPERATOR PROFILE.................................................................................................... 2-2
OPERATOR TRAINING.................................................................................................. 2-2
FUNCTIONAL DESCRIPTION........................................................................................ 2-2
Thyroid Uptake............................................................................................................ 2-2
Wipe Test .................................................................................................................... 2-3
Lab Tests .................................................................................................................... 2-3
Urine Tests ............................................................................................................. 2-3
Blood Tests............................................................................................................. 2-3
Bioassay ..................................................................................................................... 2-4
TECHNICAL DESCRIPTION .......................................................................................... 2-4
Detector ...................................................................................................................... 2-4
Multi-Channel Analyzer ............................................................................................... 2-5
TECHNICAL SPECIFICATIONS ..................................................................................... 2-6
System Hardware........................................................................................................ 2-6
Detectors, Data Acquisition, and Computer ............................................................ 2-6
Floor Stand ............................................................................................................. 2-6
Isolation Transformer .............................................................................................. 2-6
Printer ..................................................................................................................... 2-6
Computer System (Minimum System Requirements).............................................. 2-7
CAP-MCA ............................................................................................................... 2-7
TUS Probe Detector................................................................................................ 2-8
Well Detector – Optional ......................................................................................... 2-8
Environment Requirements ......................................................................................... 2-8
Operational ............................................................................................................. 2-8
Storage ................................................................................................................... 2-9
Warm Up Period.......................................................................................................... 2-9
System Power Requirements ...................................................................................... 2-9
Input Power ............................................................................................................ 2-9
Isolation Transformer Output .................................................................................. 2-9
Printer ................................................................................................................... 2-10
Regulatory Listings.................................................................................................... 2-10
EMC ..................................................................................................................... 2-10
Safety ................................................................................................................... 2-10

November 16 TABLE OF CONTENTS TOC-1

CAPINTEC, INC. CAPTUS® 4000e

GENERAL OPERATING INSTRUCTIONS.........................................................................3-1
INTRODUCTION .............................................................................................................3-1
WINDOWS OPERATING CONVENTIONS......................................................................3-1
Common Controls and Techniques ..............................................................................3-1
Windows Controls ........................................................................................................3-2
Pointing Device Cursor............................................................................................3-2
Command Button ....................................................................................................3-3
Frame......................................................................................................................3-3
Text Entry Box.........................................................................................................3-4

Scroll Bars ....................................................................................3-5

Spin Control ..................................................................................................3-6

List Controls ............................................................................................................3-6

Menu Bars...............................................................................................................3-6

Buttons ....................................................................................................................3-6

Keyboard Control ....................................................................................................3-7

CAPTUS SCREENS........................................................................................................3-7

Typical Test Screen .....................................................................................................3-9

Typical Input Screen ..................................................................................................3-10

Measurement Screen.................................................................................................3-11

Add Comments Screen ..............................................................................................3-12

SHORTCUT KEYS ........................................................................................................3-13

All Screens.................................................................................................................3-13

Input Screens.............................................................................................................3-13

GENERAL SETUP .............................................................................................................4-1
INSTALLATION ...............................................................................................................4-1
ENVIRONMENT REQUIREMENTS.................................................................................4-3
Operational ..................................................................................................................4-3
Storage ........................................................................................................................4-3
POWER REQUIREMENTS .............................................................................................4-4
Input Power..................................................................................................................4-4
Isolation Transformer Output........................................................................................4-4
TURN ON PROCEDURE ................................................................................................4-4
LOG ON ..........................................................................................................................4-5
Sign In .........................................................................................................................4-6
Sign Off........................................................................................................................4-6
Admin Log On..............................................................................................................4-6
User Log On ................................................................................................................4-7
Add User .........................................................................................................................4-8
Add User – Staff Member.............................................................................................4-8
Add User – Not a Staff Member ...................................................................................4-9
Change Password .........................................................................................................4-10
LOG ON REPORT.........................................................................................................4-11
Displaying Selected User ...........................................................................................4-12
Delete User................................................................................................................4-12
Invalidate User ...........................................................................................................4-13
Revalidate User .........................................................................................................4-13
Displaying Data by Date.............................................................................................4-13

TOC-2 TABLE OF CONTENTS November 16

CAPINTEC, INC. CAPTUS® 4000e

Printing Report .......................................................................................................... 4-13
Exiting ....................................................................................................................... 4-14
FIRST TIME STARTUP ................................................................................................ 4-14
System Parameters................................................................................................... 4-15
Quality Assurance Tests............................................................................................ 4-16

Reference Pages .................................................................................................. 4-17
Measurement Setups ................................................................................................ 4-17

Reference Pages .................................................................................................. 4-18
NORMAL STARTUP..................................................................................................... 4-18

QUALITY ASSURANCE .................................................................................................... 5-1
INTRODUCTION ............................................................................................................ 5-1
Recommended Routine for CAPTUS® 4000e System ................................................. 5-1
SETTING UP QA PARAMETERS................................................................................... 5-2
AUTO CALIBRATION ..................................................................................................... 5-5
About Auto Calibration............................................................................................... 5-10
CONSTANCY TEST ..................................................................................................... 5-11
CHI-SQUARE TEST ..................................................................................................... 5-15
MDA TEST.................................................................................................................... 5-19
VIEWING SYSTEM PARAMETERS ............................................................................. 5-23
VIEWING AND PRINTING HISTORY ........................................................................... 5-24

ISOTOPES......................................................................................................................... 6-1
INTRODUCTION ............................................................................................................ 6-1
VIEWING AND PRINTING ISOTOPE LIBRARY ............................................................. 6-2
ADDING A NEW ISOTOPE TO THE LIBRARY .............................................................. 6-3
EDITING ISOTOPE INFORMATION............................................................................... 6-4
DELETING AN ISOTOPE ............................................................................................... 6-5
MEASURING EFFICIENCY ............................................................................................ 6-5
ENTERING EFFICIENCY ............................................................................................... 6-9

THYROID UPTAKE ........................................................................................................... 7-1
INTRODUCTION ............................................................................................................ 7-1
QUICK STEP GUIDE FOR THYROID UPTAKE PROCEDURE ...................................... 7-3
MEASUREMENT PROTOCOLS..................................................................................... 7-3
Counting Methods ....................................................................................................... 7-3
Dose Administration .................................................................................................... 7-4
Adding Protocols ......................................................................................................... 7-5
Editing Protocols ......................................................................................................... 7-7
Deleting Protocols ....................................................................................................... 7-9
Printing Protocol Report ............................................................................................ 7-10
PATIENT INFORMATION............................................................................................. 7-10
Adding Patients ......................................................................................................... 7-10
Viewing Patient Information....................................................................................... 7-13
Editing Patient Information ........................................................................................ 7-13
Deleting Patient Records........................................................................................... 7-15
VIEWING AND CHANGING THE SETUP ..................................................................... 7-16
MAKING MEASUREMENTS......................................................................................... 7-18

November 16 TABLE OF CONTENTS TOC-3

CAPINTEC, INC. CAPTUS® 4000e

Counting Selected Patient..........................................................................................7-20
Administering Dose....................................................................................................7-24
RESULTS......................................................................................................................7-24
Patients Reports ........................................................................................................7-25

WIPE TESTS ......................................................................................................................8-1
INTRODUCTION .............................................................................................................8-1
QUICK STEP GUIDE FOR WIPE TEST ..........................................................................8-3
SETTING UP DEFAULTS ...............................................................................................8-3
SELECTING ISOTOPES FOR WIPE TEST.....................................................................8-4
ADDING WIPE LOCATIONS TO PRESET GROUPS......................................................8-6
ADDING WIPE LOCATIONS TO USER DEFINED GROUPS..........................................8-7
EDITING WIPE LOCATION INFORMATION ...................................................................8-8
DELETING WIPE TEST LOCATION .............................................................................8-10
MAKING MEASUREMENTS .........................................................................................8-12
Results.......................................................................................................................8-17
VIEWING AND PRINTING RESULTS ...........................................................................8-18
Search .......................................................................................................................8-19
Viewing Wipe Test Data Selectively ......................................................................8-21
Selecting Results...................................................................................................8-22
Exporting Wipe Test Results .................................................................................8-22
Printing Wipe Test Results ....................................................................................8-23
Exiting Search .......................................................................................................8-23
Summary Reports ......................................................................................................8-24
Printing Wipe Test Summary Report .....................................................................8-29
Exiting Summary Reports ......................................................................................8-30
ISOTOPE EFFICIENCY ................................................................................................8-30

ABSORBED DOSE ALERT................................................................................................9-1
INTRODUCTION .............................................................................................................9-1
Basis for Conversion Calculations................................................................................9-2
MAIN SCREEN ...............................................................................................................9-2
INCIDENT SETUP...........................................................................................................9-4
Setup Incident Parameters...........................................................................................9-4
Incident / Site ID ......................................................................................................9-4
Date of Intake ..........................................................................................................9-4
Select Isotope..........................................................................................................9-5
Screening Level.......................................................................................................9-5
Counting Parameters Frame ...................................................................................9-5
Repetitions Frame ...................................................................................................9-5
New Incident ................................................................................................................9-6
Select Incident .............................................................................................................9-6
Delete Incident.............................................................................................................9-8
Edit Incident .................................................................................................................9-9
ADDING PATIENTS ......................................................................................................9-11
EDITING PATIENTS .....................................................................................................9-14
DELETING PATIENTS ..................................................................................................9-15
MAKING MEASUREMENTS .........................................................................................9-16
Data Acquisition .........................................................................................................9-20

TOC-4 TABLE OF CONTENTS November 16

CAPINTEC, INC. CAPTUS® 4000e

CREATING AN ARCHIVE............................................................................................. 9-21
OPENING AN ARCHIVE............................................................................................... 9-22
PATIENT REPORTS .................................................................................................... 9-23

Displaying and Printing.............................................................................................. 9-23
Exporting ................................................................................................................... 9-26

LAB TESTS ..................................................................................................................... 10-1
INTRODUCTION .......................................................................................................... 10-2
SCHILLING TEST......................................................................................................... 10-3
Setup Counting Parameters ...................................................................................... 10-4
Adding Patients ......................................................................................................... 10-5
Editing Patient Information ........................................................................................ 10-7
Deleting Patient Information ...................................................................................... 10-8
Making Measurements ............................................................................................ 10-10
Data Acquisition.................................................................................................. 10-14
Test Results ............................................................................................................ 10-15
Patients Reports ................................................................................................. 10-15
I 125 BLOOD VOLUME TEST .................................................................................... 10-18
Setup Counting Parameters .................................................................................... 10-19
Adding Patients ....................................................................................................... 10-21
Editing Patient Information ...................................................................................... 10-24
Deleting Patient Information .................................................................................... 10-25
Making Measurements ............................................................................................ 10-26
Test Results ............................................................................................................ 10-30
Patients Reports ................................................................................................. 10-30
Cr51 BLOOD VOLUME TEST..................................................................................... 10-30
Setup Counting Parameters .................................................................................... 10-31
Adding Patients ....................................................................................................... 10-33
Editing Patient Information ...................................................................................... 10-35
Deleting Patient Information .................................................................................... 10-37
Making Measurements ............................................................................................ 10-38
Test Results ............................................................................................................ 10-42
Patients Reports ................................................................................................. 10-42
RBC SURVIVAL TEST................................................................................................ 10-43
Setup Counting Parameters .................................................................................... 10-44
Adding Patients ....................................................................................................... 10-45
Editing Patient Information ...................................................................................... 10-46
Deleting Patient Information .................................................................................... 10-47
Making Measurements ............................................................................................ 10-48
Test Results ............................................................................................................ 10-51
Patients Reports ................................................................................................. 10-52

BIOASSAY ...................................................................................................................... 11-1
INTRODUCTION .......................................................................................................... 11-1
BIOASSAY SETUP....................................................................................................... 11-2
I 131/I 125 and I 123/1 125 Cross Contamination...................................................... 11-9
ADDING STAFF MEMBERS......................................................................................... 11-9
EDITING STAFF MEMBER INFORMATION............................................................... 11-10
DELETING STAFF MEMBER ..................................................................................... 11-11

November 16 TABLE OF CONTENTS TOC-5

CAPINTEC, INC. CAPTUS® 4000e

MAKING MEASUREMENTS .......................................................................................11-12
VIEWING AND PRINTING REPORTS ........................................................................11-15

TIME ACTIVITY ANALYSIS .............................................................................................12-1
INTRODUCTION ...........................................................................................................12-1
SETTING UP PARAMETERS........................................................................................12-2
MAKING MEASUREMENTS .........................................................................................12-5
Saving the Results .....................................................................................................12-8
VIEWING PREVIOUSLY SAVED RESULTS .................................................................12-9

MCA .................................................................................................................................13-1
INTRODUCTION ...........................................................................................................13-1
ACQUISITION AND COUNT DATA...............................................................................13-2
Channel Data Display ................................................................................................13-2
CHANGING DETECTORS ............................................................................................13-3
SPECTRUM SCALE & ZOOMING ................................................................................13-3
Vertical Zoom.............................................................................................................13-3
Horizontal Zoom.........................................................................................................13-4
Pre-Defined Channel Ranges................................................................................13-4
User Selectable Range..........................................................................................13-5
COUNTING SETUP ......................................................................................................13-7
SPECTRUM ID (NAME) ................................................................................................13-7
REGIONS OF INTEREST (ROI)....................................................................................13-8
SAVE AND RESTORE COUNT DATA OR MCA SETTINGS.......................................13-10
Save Spectrum ........................................................................................................13-10
Recall Spectrum.......................................................................................................13-11
Export to Excel.........................................................................................................13-12
Export Raw Spectrum ..............................................................................................13-13
Save MCA Settings..................................................................................................13-13
Recall MCA Settings ................................................................................................13-13
Save Counting Setup ...............................................................................................13-13
Recall Counting Setup .............................................................................................13-14
Restore Current Settings..........................................................................................13-14
PRINTING MCA DATA ................................................................................................13-14
CUSTOMIZING MCA SETTINGS................................................................................13-14
High Voltage ............................................................................................................13-15
Gain .........................................................................................................................13-15
Zero Offset...............................................................................................................13-16
Threshold.................................................................................................................13-16
MANUAL CALIBRATION.............................................................................................13-17

ARCHIVE..........................................................................................................................14-1
INTRODUCTION ...........................................................................................................14-1
DOING SYSTEM BACKUP (CREATING AN ARCHIVE) ...............................................14-3
OPENING AN ARCHIVE ...............................................................................................14-4
VIEWING AND PRINTING RECORDS FROM ARCHIVE..............................................14-5
Selecting Tests for Viewing........................................................................................14-5
Viewing or Printing a Record......................................................................................14-6

TOC-6 TABLE OF CONTENTS November 16

CAPINTEC, INC. CAPTUS® 4000e

Printing All Records in Selected Tests....................................................................... 14-8

CUSTOM PROTOCOLS .................................................................................................. 15-1
INTRODUCTION .......................................................................................................... 15-1
STARTING CUSTOM PROTOCOLS ............................................................................ 15-2
PROTOCOLS ............................................................................................................... 15-3
Adding Protocols ....................................................................................................... 15-3
Viewing Protocols...................................................................................................... 15-7
Deleting Protocols ..................................................................................................... 15-7
Deleting Selected Protocols .................................................................................. 15-7
Deleting All Protocols............................................................................................ 15-7
Selecting the Excel Workbook for the Protocol .......................................................... 15-7
PATIENT DATA ............................................................................................................ 15-8
Adding Patients ......................................................................................................... 15-8
Editing Patient Information ...................................................................................... 15-10
Deleting Patient Information .................................................................................... 15-10
Deleting Selected Patients .................................................................................. 15-10
Deleting All Patients............................................................................................ 15-11
MAKING MEASUREMENTS....................................................................................... 15-12
Data Acquisition ...................................................................................................... 15-13
After Counting ......................................................................................................... 15-15
Report ..................................................................................................................... 15-15
CUSTOM PROTOCOLS EXCEL WORKBOOK .......................................................... 15-16
Creating a Workbook for a Protocol (Setup Mode) .................................................. 15-16
Setting Up the Workbook......................................................................................... 15-18
Protocol Selection............................................................................................... 15-19
Patient Selection................................................................................................. 15-20
Entering Formulas .............................................................................................. 15-22
Creating a Report ............................................................................................... 15-23
Viewing Patients from Workbook (User Mode) ........................................................ 15-24

CLEANING AND MAINTENANCE................................................................................... 16-1
INTRODUCTION .......................................................................................................... 16-1
CLEANING and DISINFECTING................................................................................... 16-2
Cleaning Instructions................................................................................................. 16-2
Disinfecting Instructions............................................................................................. 16-4
Liner ..................................................................................................................... 16-4
Printer ................................................................................................................... 16-4
PREVENTIVE MAINTENANCE .................................................................................... 16-4
DISPOSAL.................................................................................................................... 16-5
SERVICING .................................................................................................................. 16-6
Collimator Block Inspection ....................................................................................... 16-6
Spring-Arm Inspection............................................................................................... 16-7
Computer Battery Replacement ................................................................................ 16-9
FUSE SERVICING........................................................................................................ 16-9
Power Line Fuses...................................................................................................... 16-9
Computer and Printer Fuses ................................................................................... 16-11
ACCESSORIES AND REPLACEMENT PARTS ......................................................... 16-12
SHIPPING................................................................................................................... 16-13

November 16 TABLE OF CONTENTS TOC-7

CAPINTEC, INC. CAPTUS® 4000e

Cap-DICOM ......................................................................................................................17-1
INTRODUCTION ...........................................................................................................17-1
CONFIGURING Cap-DICOM.........................................................................................17-1
License Information....................................................................................................17-1
Settings......................................................................................................................17-4
AE Title..................................................................................................................17-5
Text Color..............................................................................................................17-5
Display Patient ......................................................................................................17-5
Study Date ............................................................................................................17-5
Institution Information ............................................................................................17-5
Worklist Provider........................................................................................................17-6
Adding Worklist Provider .......................................................................................17-6
Editing Worklist Provider .......................................................................................17-8
Deleting Worklist Provider .....................................................................................17-9
Storage Provider ......................................................................................................17-10
Adding Storage Provider .....................................................................................17-10
Editing Storage Provider......................................................................................17-12
Deleting Storage Provider....................................................................................17-13
IMPORTING PATIENTS..............................................................................................17-14
Query Worklist .........................................................................................................17-14
Start Date/End Date ............................................................................................17-16
Modality ...............................................................................................................17-16
Scheduled Station AE Title ..................................................................................17-16
Schedule Performing Physicians Name...............................................................17-16
Accession Number, Patient Id and Patient Name ................................................17-17
Import Patient ..........................................................................................................17-17
VIEWING THE DICOM REPORT ................................................................................17-18
EXPORTING A STUDY ...............................................................................................17-20
VERIFYING STUDY ....................................................................................................17-21

INDEX

WARRANTY

DECLARATION OF CONFORMITY

TOC-8 TABLE OF CONTENTS November 16

CAPINTEC, INC. CAPTUS® 4000e

PREFACE

GENERAL ........................................................................................................ 1
SYSTEM DESCRIPTION.................................................................................. 1
MEDICAL EQUIPMENT SAFETY CLASSIFICATION...................................... 2
ELECTROMAGNETIC INTERFERENCE POTENTIAL .................................... 2
INSTALLATION ............................................................................................... 3
IMPORTANT SAFETY INFORMATION............................................................ 3
TRADEMARKS ................................................................................................ 3

GENERAL
Thank you for purchasing the Capintec line of Thyroid Uptake Measurement Systems. Every
effort has been made to ensure that the information in this document is complete, accurate,
and up-to-date. Mention of products manufactured by other companies does not necessarily
constitute endorsement by Capintec, Inc. Capintec assumes no responsibility for the results
of errors beyond its control.

Please address any comments pertaining to this manual to:

Capintec, Inc.
7 Vreeland Road
Florham Park, NJ 07932
Phone (800) ASK-4CRC
Fax (201) 825-1336

Note: Federal Law restricts this device to sale by or on the order of a physician,
pharmacist or other licensed professional.

SYSTEM DESCRIPTION
Your new CAPTUS® 4000e is available in several configurations. Please take a moment to
review your system to determine exactly the configuration you have received. The basic
Thyroid Uptake System consists of the following:

• Floor Stand or Optional Table Top Stand
• TUS Collimator
• Isolation Transformer
• NaI (sodium iodide) Detector with Detector Socket Base

Note: Two versions of detectors are available: Flat Face or Drilled.

July 16 PREFACE p-1

CAPINTEC, INC. CAPTUS® 4000e

• All-in-One Touchscreen Computer System
• CAP-MCA
• Printer
• Cables for connecting detector, printer, etc.
• 15 foot power cord with hospital grade plug
• Software and Documentation
• Windows 8.1 or later,
• CAPTUS® 4000e Manual and Installation Disks or CDs
• Optional Well Counter with drilled Well Detector

MEDICAL EQUIPMENT SAFETY CLASSIFICATION
• CLASS I EQUIPMENT energized from an external power source
• TYPE B EQUIPMENT with applied part (Positioning Rod)
• Ordinary EQUIPMENT without protection against the ingress of water
• Suitable for CONTINUOUS OPERATION
• NOT suitable for use in the presence of a an FLAMMABLE ANAESTHETIC
MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE

ELECTROMAGNETIC INTERFERENCE POTENTIAL
This equipment complies fully with interference immunity requirements of the standard IEC
60601-1-2 “Medical electrical equipment: Part 1: General safety requirements; 2.
Supplementary standard: Electromagnetic compatibility”.

This equipment generates radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to nearby devices.
However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference, the user is encouraged to try to correct the
interference by one of the following measures:

• Increase the separation between the equipment and the affected device.

• Plug the unit into an outlet on a circuit different from that which the affected device is
connected.

If this fails to correct the problem, please contact Capintec’s only Authorized Service Center.

p-2 PREFACE July 16

CAPINTEC, INC. CAPTUS® 4000e

INSTALLATION

Your system has been shipped from the factory pre-configured and fully tested. Installation
consists of placing the components and securing them in place. Detailed installation and
assembly instructions are provided in the included Unpacking and Assembly Instructions
for your system.

IMPORTANT SAFETY INFORMATION
The CAPTUS® 4000e measurement system has been carefully designed to give you years of
safe and reliable performance. As with all electrical equipment, however, there are basic
precautions you must observe to avoid injuring yourself, the patient or damaging the
equipment.

• Follow the unpacking and assembly instructions document, and read this manual
carefully before using this equipment. Be sure to save all provided documents for
future reference.

• Understand all warning and caution labels as explained in the CHAPTER 1:
SAFETY before operating this equipment.

TRADEMARKS
CAPTUS® 4000e and CII are registered trademarks of Capintec, Inc.

Microsoft® and MS Windows® are U.S. registered trademarks of the Microsoft Corporation.

Hewlett Packard® Officejet is a registered trademark of the Hewlett Packard Company.

July 16 PREFACE p-3

CAPINTEC, INC. CAPTUS® 4000e

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CAPINTEC, INC. CAPTUS® 4000e

CHAPTER 1

SAFETY

GENERAL .......................................................................................................1-1
SYMBOL DEFINITIONS..................................................................................1-1
WARNING AND CAUTION LABELS ..............................................................1-2
CAUTIONS AND NOTES ................................................................................1-3
GENERAL SAFETY TIPS ...............................................................................1-6

GENERAL

These warnings and instructions form an integral part of the CAPTUS® 4000e system and
must be kept available for consultation at all times. Precise compliance with the warnings
and instructions is an essential condition for correct usage and safety of patients and users.

SYMBOL DEFINITIONS

Dangerous Voltage Present
Protective Earth Ground
Caution
Operator should consult accompanying documents
Fuse
AC Voltage
DC Voltage
“ON” (power)
“OFF” (power)
Date of Manufacture
CE Mark

July 16 SAFETY 1-1

CAPINTEC, INC. CAPTUS® 4000e

Waste in Electrical and Electronic Equipment (WEEE) –
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately.
Environmentally Friendly Use Period (EFUP) – 20 years
from the date of manufacture – Toxic or hazardous
substances or elements contained in the unit will not leak
or mutate under normal operating conditions resulting in
any environmental pollution, bodily injury or damage to
assets.

WARNING AND CAUTION LABELS

Located on the Isolation Transformer is a label (Figure 1-1) providing the system power
requirements, the voltage of the system, the replacement fuse values for both power line
voltages and the fuse replacement warning.

Figure 1-1

CAUTION: Please reference CHAPTER 16: CLEANING AND MAINTENANCE
for instructions on how to change the fuses of the Isolation
Transformer.

CAUTION: For continued protection, replace only with same type and rating of
fuse(s). A fire hazard may exist if the wrong rating of fuse is installed.

1-2 SAFETY July 16

CAPINTEC, INC. CAPTUS® 4000e

Located by each line cord on the Isolation Transformer is a label (Figure 1-2) indicating
which device each cord is to be connected to and the power availability for that device.

Figure 1-2

CAUTIONS AND NOTES

CAUTION: Changing the date or time while a timed test is in progress (for example,
a 24 hour Thyroid Uptake Test) might affect the results or introduce
unexpected error. Care should be taken to evaluate any potential impact
for ongoing tests before changing the date or time. Verify that in the Date
and Time Properties in Windows Control Panel that the “Automatically
adjust clock for daylight saving changes” checkbox is not checked.

CAUTION: Only qualified/trained personnel should operate or service this unit.

CAUTION: If the equipment is used in a manner not specified in this manual, the
protection provided by the equipment may be impaired.

CAUTION: High voltage is present inside the Detectors (up to 1000 Volts). Due to
the presence of this high voltage, opening the covers with the system
plugged in may be hazardous. Refer all servicing to qualified personnel.

CAUTION: The assembled CAPTUS® 4000e system is very heavy (up to a
maximum of 740lb [336kg] fully loaded) Use caution when moving.
Reference CHAPTER 4: GENERAL SETUP, Section: Moving the
System for moving instructions.

CAUTION: There are no internal adjustments inside the detector, computer or
printer that should be performed by the user within the conditions of the
warranty, except for changing the Isolation Transformer fuse. Due to the
presence of high voltages, opening the cover of the computer with the
system plugged in may be hazardous. Refer all servicing to qualified
personnel.

July 16 SAFETY 1-3

CAPINTEC, INC. CAPTUS® 4000e

CAUTION: Never use the Well Detector without the well liner in place. Liners are
inexpensive and easy to replace. A contaminated detector is a very
costly mistake. If unit becomes contaminated remove liner and clean unit
as stated in CHAPTER 16: CLEANING AND MAINTENANCE before
operating.

CAUTION: Care must be exercised when moving the system or when maintenance
is performed. If the system is inclined at more than a 15-degree angle, it
may tip over.

CAUTION: Verify that the collimator is correctly installed as stated in the
UNPACKING AND ASSEMBLY INSTRUCTIONS. Failure to follow these
instructions could result in injury or product malfunction.

CAUTION: This equipment generates radio frequency energy and is susceptible to
radio frequency energy (such as from other equipment and portable and
mobile RF communications equipment). The equipment needs to be
installed and used accordingly with these instructions; otherwise the
equipment may not function properly or may cause harmful
Electromagnetic Interference (EMI) to nearby devices. There is,
however, no guarantee that interference will not occur in a particular
installation/location.

CAUTION: If any Computer, Printer or cables other than the model supplied by

Capintec is used, the safety of the unit may be compromised or other
devices located in the same general area as the CAPTUS® 4000e may

become susceptible to EMI.

CAUTION: If any detectors other than those supplied by Capintec are used, the

safety of the unit may be compromised or other devices located in the
same general area as the CAPTUS® 4000e may become susceptible to

EMI.

CAUTION: If any components are used other than those supplied by Capintec, the
power and signal connections must be the same as those for the original
manufacturer’s configuration or the safety of the unit may be
compromised.

CAUTION: The equipment should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the
equipment should be observed to verify normal operation in the
configuration in which it will be used.

CAUTION: Do not disconnect or connect detectors from the computer, while the
system is on. Shut down the computer first.

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CAPINTEC, INC. CAPTUS® 4000e

CAUTION: Only the included USB devices should be connected to the USB ports on

the Computer. If any USB devices other than the models supplied by

Capintec are used, the safety of the unit may be compromised or other
devices located in the same general area as the CAPTUS® 4000e may

become susceptible to EMI. The maximum Input/Output voltages are
5Vdc.

CAUTION: Do not attach a monitor to the VGA port on the rear of the Computer. If a

Monitor is attached to this port, the safety of the unit may be

compromised or other devices located in the same general area as the
CAPTUS® 4000e may become susceptible to EMI.

CAUTION: Do not connect the CAPTUS® 4000e to a network. If the system is

attached to a network, the safety of the unit may be compromised or
other devices located in the same general area as the CAPTUS® 4000e

may become susceptible to EMI.

CAUTION: The unit contains lead. The unit should be disposed of in accordance
with local and national regulations.

CAUTION: The unit contains a lithium battery. This should be disposed of in
accordance with local and national regulations.

CAUTION: The user should always verify the validity of any measurement or test
result in order to minimize measurement errors.

CAUTION: To remove main power from the system, the Isolation Transformer power
cable must be unplugged from the medical grade wall socket.

WARNING: The CAPTUS® 4000e must be connected a supply mains with protective
earth.

Note: It is recommended that periodic (every five years) re-calibration of the unit be
performed only by Capintec’s Authorized Service Center (reference CHAPTER 16:
CLEANING AND MAINTENANCE) to guarantee that the instrument's high reliability is
maintained).

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CAPINTEC, INC. CAPTUS® 4000e

GENERAL SAFETY TIPS
• Unplug the equipment before cleaning it. Use only a damp cloth; do not use solvents
or aerosol cleaners.

• To protect the equipment from overheating, make sure none of the openings (vents)
on the computer, monitor or the printer are blocked.

• Do not use the equipment directly in front of a radiator, heat register or air
conditioning duct.

• Do not use the equipment near water or spill liquids of any kind into the equipment.

• Be sure that your power source matches the rating listed on the Isolation
Transformer.

• The CAPTUS® 4000e power cord has a grounded, 3-prong plug as a safety feature,
and it will only fit into a grounded outlet. Do not use an adapter to defeat the
grounding.

• Do not position the CAPTUS® 4000e such that the mains power on/off switch at the
base of the unit cannot be accessed.

• The CAPTUS® 4000e computer system is connected to the Isolation Transformer to
comply with electrical safety for Medical Electrical Equipment.

• Due to the risk of electrical shock, do not install or use a modem or a network adapter
with the CAPTUS® 4000e computer system.

• To avoid damaging the power cord, do not place anything on it or place it where it will
be walked on. If the cord becomes damaged, replace it immediately.

• Aside from the routine maintenance described in this manual, do not try to service
this equipment yourself. There are no user serviceable parts contained in the system
other than the fuses in the Isolation Transformer. Do not make any adjustments other
than those outlined in this manual, as you may in-validate the calibration or cause
damage requiring extensive repair work. Refer servicing to qualified service
personnel.

• Do not subject the Detectors to rough handling or rapid temperature changes, as the
NaI Scintillation Crystal can be damaged.

• Do not place more 200 pounds (90.7 kg) of weight on the table top.

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CAPINTEC, INC. CAPTUS® 4000e

CHAPTER 2

FUNCTIONAL & TECHNICAL
DESCRIPTION

INTENDED USE ..............................................................................................2-1
OPERATOR PROFILE ....................................................................................2-2
OPERATOR TRAINING ..................................................................................2-2
FUNCTIONAL DESCRIPTION ........................................................................2-2

Thyroid Uptake ...........................................................................................2-2
Wipe Test ....................................................................................................2-3
Lab Tests ....................................................................................................2-3
Bioassay .....................................................................................................2-4
TECHNICAL DESCRIPTION...........................................................................2-4
Detector ......................................................................................................2-4
Multi-Channel Analyzer..............................................................................2-5
TECHNICAL SPECIFICATIONS .....................................................................2-6
System Hardware .......................................................................................2-6
Environment Requirements.......................................................................2-8
Warm Up Period .........................................................................................2-9
System Power Requirements ....................................................................2-9
Regulatory Listings...................................................................................2-10

INTENDED USE
The CAPTUS® 4000e Thyroid Uptake / Well System is intended to be used by trained
Nuclear Medicine Technologists for performing Thyroid Uptake, Thyroid Bioassay, Wipe
Test, Blood Volume (with Cr-51 or I-125) Test, Schillings Test and RBC Survival Test.

Also using the system are Health Physicists with expertise in nuclear medicine and radiation
safety – typically used for assessing reproducibility of counting instruments with various
Quality Assurance procedures (Chi-Square, Linearity, Constancy, Accuracy, etc.).

The CAPTUS® 4000e also performs Pulse Height Analysis, isotope identification,
radioisotope decay corrections, efficiency calculations and maintains a database for storage
and easy retrieval of patient demographic data and measurement results.

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OPERATOR PROFILE
The operator profile for the Nuclear Medicine Technologists, Physicians and Health
physicists is as follows:

• Education:
o Minimum: at least an Associate Degree
o No maximum

• Knowledge:
o Minimum: Understands the basic concepts of nuclear medicine.
o No maximum

• Language Understanding:
o English
o Other languages are available for instructions for use

• Experience:
o Minimum: Has minimum training or is under surveillance by a trained user.
o No maximum

OPERATOR TRAINING
This Owner’s Manual contains all of the information required to operate the CAPTUS® 4000e.

FUNCTIONAL DESCRIPTION

Thyroid Uptake

Thyroid uptake is a measurement of the ratio of the amount of radioactive material
concentrated in the thyroid gland to the amount of radioactive material administered to the
patient. Thyroid uptake measurements are generally used to determine conditions of
hyperthyroidism. High uptake results are found in Graves’ disease, toxic nodular goiter, and
stimulator secreting tumors or can be TSH-induced. Low uptake results are found with
thyroid hormone secretion in ectopic tumors, hormonal release in thyroid injury, after intake
of thyroid hormone, or in Jod-Basedow disease. During the treatment of thyroid cancer by I-
131 ablation, uptake measurements are used to monitor thyroid activity.

The CAPTUS® 4000e system will store patient demographic and dosage information, count
data for both the administered dosage and the patient, decay correct all count data, calculate
thyroid uptake results, and store all of this information in the thyroid uptake database.
Regions of Interest have been defined for three isotopes, I-131, I-123, or Tc-99m. If normal
values have been entered, results exceeding these values will be flagged. All of the patient
information may be printed. The thyroid uptake software has been designed to accommodate
a variety of different counting protocols, using either capsules or liquid dosages.

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CAPINTEC, INC. CAPTUS® 4000e

Wipe Test

The Wipe Test measures radioactive contamination for nuclear medicine departments and
laboratories, as mandated by state and federal radiation safety requirements.

Note: A Drilled Probe for the Collimator or an optional external Well Counter is required for
Wipe measurements.

Lab Tests

Urine Tests
Schilling Test
The Schilling Test utilizes Cobalt 57 labeled Vitamin 12 and is used to determine B-
12 deficiencies from either malabsorption, lack of intrinsic factor (pernicious anemia),
or intraintestinal destruction. The test entails collection of urine for 24 or 48 hours
after the oral administration of radioactive labeled vitamin B-12. The ratio of excreted
to administered Co57 is calculated. If the initial results indicate a reduced amount of
excreted vitamin, the test is repeated with a second sample of labeled B-12 and
intrinsic factor. For Schilling Test I, abnormal results are generally less than 8%-10%.
Normal range is generally 11% to 26%. For Schilling Test II, no change indicates
malabsorption, while an improved percentage indicates pernicious anemia.

Blood Tests

Blood Volume Tests

Blood Volume determinations involving radioactive tagging are most frequently used
in specific disease conditions when the hematocrit may not accurately estimate true
blood volume. Such conditions include extensive trauma or burn patients, certain
types of anemia, and polycythemia. Most frequently used radioactive tracers are
protein labeled I125 for plasma measurements and Cr51 tagged RBCs for red cell
mass determinations.

RBC Survival Test

RBC survival determination involving radioactive tagging is most frequently used in
diagnosis of hemolytic anemia. The CAPTUS® 4000e software and default counting
parameters follow the testing protocol outlined in the Mallinckrodt RBC Survival
Instructions that utilize Sodium Chromate Cr51 Injections. The software standardizes
the 24-hour sample to 100% survival, and automatically decay corrects each
subsequent sample. This permits the user to measure each sample as soon as it is
collected. For this reason, all sample volumes must be the same. Each sample must
also have a hematocrit (HCT) measurement. The subsequent samples are corrected
for any differences in hematocrit.

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Bioassay

All staff members who work with Iodine-131, Iodine-125, or Iodine-123 need to have regular
Bioassay measurements taken to monitor exposure levels. Most state and federal radiation
safety regulations mandate that these thyroid measurements be taken periodically.

The CAPTUS® 4000e uses one bioassay protocol, which is user-defined. Before performing
bioassay measurements on the staff, the staff member names and ID numbers should be
added to the database and parameters for the bioassay protocol should be set up.

TECHNICAL DESCRIPTION
The CAPTUS® 4000e is a PC based application running on the Windows® operating system.

The basic Thyroid Uptake system consists of the following:

• Floor Stand or Optional Table Top Stand
• TUS Collimator
• Isolation Transformer
• NaI (sodium iodide) Detector with Detector Socket Base

Note: Two versions of detectors are available: Flat Face or Drilled.
• All-in-One Touchscreen Computer System with software installed to switch inputs and

perform multi-channel analysis
• CAP-MCA hardware
• Printer
• Cables for connecting Detector, CAP-MCA, etc.
• 15 foot power cord with hospital grade plug
• Windows 8.1 or later,
• CAPTUS® 4000e Software Installation CD including Owner’s Manual
• Optional Well Counter with drilled Well Detector

Detector
The CAPTUS® 4000e system is equipped with one or two NaI (Tl) (Thallium-activated
Sodium Iodide) crystal and photomultiplier tube detector assemblies, a 1024 channel MCA
(Multi-Channel Analyzer), along with associated electronics and electronic controls which
provide power and amplification of the pulses generated by the detectors, as well as software
modules which record, analyze, manipulate, and store the measured data.

Since NaI crystals are hygroscopic, the detector assemblies are hermetically sealed with an
aluminum coating. If the seal is broken, then water will be absorbed by the crystal, causing
deterioration of its measurement capabilities, and eventually it will require replacement. For
this reason, always handle the detector with care. Avoid scratching the surface with metal
objects such as pens.

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When a gamma or x-ray from a radioactive source reaches the NaI crystal, it collides with the
electrons in the crystal matrix and transfers energy, primarily through Compton interaction.
The excited electron releases this energy as visible light in direct proportion to its absorbed
energy. For this reason, NaI detectors are classified as scintillation detectors. The higher the
energy of the incident ray, the more Compton collisions and consequently the more visible
light emissions will be measured before all of the energy is absorbed. These sequential
emissions of light for each incident ray generated from the sequential Compton collisions
appear to the measuring system as a single light pulse. The intensity of the pulse is directly
proportional to the energy of the incident gamma or x-ray. The light is eventually directed
toward the photomultiplier tube, either by the direction in which it was emitted or by reflection
from the interior of the aluminum housing. The photomultiplier tube, which is optically
connected to the sodium iodide crystal, converts the visible light pulses into electrical energy
and amplifies the signal through a series of dynodes. The resultant electrical signal is directly
proportional to the intensity of the incident light pulse. Therefore, the pulse height generated
by the system is directly proportional to the energy of the incident gamma or x-ray detected
by the system.

Multi-Channel Analyzer

A Multi-Channel Analyzer records the number and height of the electrical pulses generated
by the system, divides the pulses into groups based upon pulse height, and provides a
visible picture or spectrum of the pulses as well as count information. The CAPTUS® 4000e
divides the pulses into 1024 groups or channels. Since pulse height is directly related to the
energy of the incident photon, the spectrum displays the pulse heights as a graph of pulses
or counts on the vertical scale and energy on the horizontal scale. By matching the displayed
spectrum to the decay scheme of an isotope, positive identification of the radioactive source
can be achieved.

Electronics associated with the process include the high voltage power supply, amplifiers,
and gain adjustments. The high voltage power supply provides voltage to the photomultiplier
tube for the light to electrical impulse conversion and amplification process. The amplifiers
linearly amplify the electrical signal produced by the photomultiplier tube before the signal is
passed to the MCA. The pulse height remains proportional to the energy of the incident ray.
The gain controls the amount of amplification that is performed by the card, and is adjustable
by the user.

The spectral display also has adjustments which control the pulse height that include zero
adjust and lower level discriminators (threshold). The zero adjust controls the channel used
for 0 pulse height or 0 energy. The threshold sets the limit for the lowest pulse height to be
analyzed.

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CAPINTEC, INC. CAPTUS® 4000e

TECHNICAL SPECIFICATIONS
System Hardware

Detectors, Data Acquisition, and Computer
All-in-One Touchscreen computer system including the MS Windows® operating
system, CAP-MCA, a dual input Multi-Channel Analyzer, scintillation detector(s), a
mouse or trackball pointing device, a color printer, and an easy to use CAPTUS®
4000e application software.

Floor Stand
Rugged Floor Stand with heavy duty locking casters and an articulating arm for the
positioning of the Detector/Collimator. Mounting for the Isolation Transformer and the
optional Well Detector is provided at the base of the Floor Stand.

Dimensions:
Height ....................... 167.6 cm ....... (66”)
Width ........................ 71.1 cm ......... (28”)
Depth ........................ 78.7 cm ......... (31”)
Weight ...................... 185.1 kg ........ (408 lb.)
(with optional well) .... 213.2 kg ........ (470 lb.)

Isolation Transformer
An Isolation Transformer is provided with the CAPTUS® 4000e system to ensure that
the leakage current meets IEC 60601-1 3rd Edition Medical Equipment Safety
Standard. A detachable 4.6m (15 ft) power cord, with a hospital grade plug, is
provided to connect the Isolation Transformer to the power source. Dual power line
fuses are provided at the power entry module for quick replacement.

Dimensions:
Height ....................... 11.4 cm ......... (4.5”)
Width ........................ 52.1 cm ......... (20.5”)
Depth ........................ 13.7 cm ......... (5.375”)

Printer
HP Officejet 6000 series Inkjet (or equivalent) – inkjet color printer, prints results of
studies including graphic displays.

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Computer System (Minimum System Requirements)
PC compatible, Intel® Celeron® Processor
CD-ROM Drive
500MB free Hard Drive space
4GB RAM
SVGA Graphics (1600×900, 24 bit Color)
19.5” Display (Touchscreen recommended)
Keyboard and Mouse / Trackball
MS Windows® 8.1

CAPTUS® 4000e Software Package

Stores and prints all test data results
Reference library for isotopes
User definable normal ranges on printout
Thyroid Uptake
Wipe Test
Schilling Test
Blood Volume
RBC Survival
MCA

CAP-MCA

CAP-MCA Multi-Channel Analyzer
1024 Channels
Maximum Count Rate 200,000 cps
ROI's – Automatic or Manual
QA automatic – gain adjust, energy calibration, resolution, chi-squared, constancy
Automatic efficiency calculation and storage
Adjustable Lower Level Discriminator (Threshold)
Differential Nonlinearity <2% over the top 98% of channels
Integral Nonlinearity <1% over the top 98% of channels
Adjustable Zero
Preset Live Time, Real Time, Total Counts
Automatic Peak Finding

Detector Inputs

Software control of Detector selection
SHV connectors for TUS Probe and Well Detectors

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CAPINTEC, INC. CAPTUS® 4000e

TUS Probe Detector
NaI(TI) flat face crystal / PM Tube ....5.1 x 5.1 cm ... (2” x 2”)
Monoline construction
Resolution (Full Width-Half Max) – ≤9.5% or better for Cs137

Lead Shielded Collimator
Complies with ANSI Standard N44.3-1973

Coaxial Signal/High Voltage Cable ...2.4 m ............. (8’) [maximum]

Well Detector – Optional
With attached (0.9 m (3’) maximum) Coaxial Signal/High Voltage Cable
NaI(TI) well type crystal / PM Tube...5.1 x 5.1 cm ... (2” x 2”)
Well diameter........................1.6 cm............ (0.625”)
Well depth.............................3.8 cm............ (1.5”)
Monoline construction
Resolution (Full Width-Half Max) – ≤10.0% or better for Cs137

1” Lead Shielding
Lined with brass (0.16 cm (1/16”) thick) to minimize backscatter

Thickness .............................2.5 cm............ (1”)
Height ...................................32.5 cm.......... (12.8”)
Diameter ...............................11.4 cm.......... (4.5”)
Weight ..................................27.9 kg........... (61.4 lb.)

2” Lead Shielding
Lined with brass (0.16 cm (1/16”) thick) to minimize backscatter

Thickness .............................5.1 cm............ (2”)
Height ...................................43.8 cm.......... (17.25”)
Diameter ...............................16.8 cm.......... (6.625”)
Weight ..................................93.0 kg........... (205 lb.)

Environment Requirements

Operational
The instrument should be located where the level of the background radiation is as
low and as constant as possible.

The instrument should be located where the temperature is stable within a range of
+50°F to +85°F (+10°C to +30°C) and the maximum relative humidity is 90% non-
condensing for maximum reliability and accuracy.

The instrument should be located where the barometric pressure is within a range of
27–31 inches of mercury (91–105 kilopascals).

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CAPINTEC, INC. CAPTUS® 4000e

Storage
The instrument should be stored where the temperature is stable and the range is
from +39°F to +110°F (+4°C to +43°C) and the maximum relative humidity is 90%
non-condensing for maximum reliability.

The instrument should be stored where the barometric pressure is within a range of
15–33 inches of mercury (51–112 kilopascals).

CAUTION: If these environmental requirements are not followed, the instrument may
display erroneous readings

Warm Up Period

Approximately 30 minutes should be allowed for the instrument to stabilize. While the
instrument is warming up, it is strongly recommended that you become familiar with the
CAPTUS® 4000e.

System Power Requirements

CAUTION: If the input voltage to the following items is not within the stated
limits, the unit may not function correctly or may be damaged

Input Power
Line Voltage:............. 115 or 230 Vac depending on model ordered
Line Frequency: ........ 60 or 50 Hz
Current:..................... 2.6 Ampere @ 115V
1.1 Ampere @ 230V
Fuse: For 115V use T 3.15AH, 250V, (Time Delay)
For 230V use T 2.5AH, 250V, (Time Delay)

Isolation Transformer Output
Computer and Monitor combined
Output Voltage: ......... 115Vac
Current Output: ......... 2.9A
Frequency: ................ 50/60Hz

Printer
Output Voltage: ......... 115Vac
Current Output: ......... 0.7A
Frequency: ................ 50/60Hz

CAP-MCA
Output Voltage: ......... +5Vdc
Current Output: ......... 3.0A

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CAPINTEC, INC. CAPTUS® 4000e

Printer

HP Officejet 6000 Series (or equivalent) Printer (optional)
100-240Vac, 50/60Hz, 1.5A

Regulatory Listings

The CAPTUS® 4000e has been independently tested and is manufactured in compliance
with the following Standards:

EMC

• IEC 60601-1-2 Ed. 4.0, (2014): Medical Electrical Equipment – Part 1-2:
General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests

Safety ANSI/AAMI ES60601-1:2005/A1:2012 Issued: 2012/08/20 Medical electrical
• equipment – Part 1: General requirements for basic safety and essential
performance

• CAN/CSA-C22.2 No. 60601-1:14: Third Edition Issued: 2014/03/01 – Medical
electrical equipment – Part 1: General requirements for basic safety and
essential performance

• IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical electrical equipment – Part
1-6: General requirements for basic safety and essential performance –
Collateral Standard: Usability

• IEC 62366:2014, Edition 1.1 Issued 2014/01/28 – Medical devices –
Application of usability engineering to medical devices

• IEC 62304:2006, First Edition Issued: 2006/05/09 Medical device software –
Software life cycle processes

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CHAPTER 3

GENERAL OPERATING INSTRUCTIONS

INTRODUCTION .............................................................................................3-1
WINDOWS OPERATING CONVENTIONS......................................................3-1

Common Controls and Techniques ..........................................................3-1
Windows Controls......................................................................................3-2
CAPTUS SCREENS........................................................................................3-7
Typical Test Screen....................................................................................3-9
Typical Input Screen .................................................................................3-10
Measurement Screen ................................................................................3-11
Add Comments Screen .............................................................................3-12
SHORTCUT KEYS .........................................................................................3-13
All Screens.................................................................................................3-13
Input Screens ............................................................................................3-13

INTRODUCTION
The CAPTUS® 4000e software runs on the Microsoft Windows® operating system and follows
standard Windows® interface conventions. If you are familiar with running Windows® based
programs, then you should find the CAPTUS® 4000e a very user friendly and easy to use
program. If you have never used a Windows® based program before, please read the next
section in this chapter carefully. Windows® uses very consistent techniques for user
interaction. These techniques are visual and generally oriented toward use of a pointing
device, such as a mouse or trackball. In most cases there are alternate keyboard techniques
for accomplishing the same task.

The system includes an all-in-one touchscreen computer system. Therefore, selections
throughout the program can be made using the included pointing device, your finger or a
Stylus.

WINDOWS OPERATING CONVENTIONS

Common Controls and Techniques

The CAPTUS® 4000e, like all Windows based programs, is task oriented. Each task to be
performed will consist of one or more dialog boxes, similar to that shown in Figure 3-1. Each
screen will have various controls on it, which perform functions when selected with the
pointing device or when selected from the keyboard. When you are finished with all of the
tasks on a given screen, selecting the Done or Exit button will return you to the previous
screen.

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Windows Controls

The most common Windows controls are described below. When controls are selected, they
cause functions or actions to be performed. A control can be selected in several ways;

• Using the pointing device – Positioning the pointing device cursor over the control
and clicking the left pointing device button selects the control. The pointing device
cursor takes several different shapes depending on what is going on in the program
and where it is on the screen.

• Using your finger or stylus to tap the control.

• Using the keyboard – Most controls can also be selected with the keyboard – The
Tab key on the keyboard can be used to move from one control to another. Pressing
Shift+Tab will move back one control. Once a control is selected, it can be activated
or changed with other keys. The specific keys that affect each type of control are
discussed below.

Pointing Device Cursor
The pointing device cursor is used to select items on the screen. Most of the time the
cursor appears as an arrow with a black outline filled with white. When the system is
busy doing something that will prohibit it from responding, the cursor changes to the
Wait cursor. When in MCA mode and the cursor is within the boundaries of the
spectrum display, the cursor changes to a double-ended vertical arrow .

When the cursor is hovered over a text box, it will change to a thin vertical “I-beam” .
Note that actually having the ability to input or edit requires that you click the pointing
device button to cause the edit cursor, a blinking vertical line, to appear.

Figure 3-1

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CAPINTEC, INC. CAPTUS® 4000e

Command Button
The most common control in the CAPTUS® 4000e is the command button, for

example the command button. A command button can be activated as
described below:

• positioning the pointing device over the button and clicking the pointing
device's left button once,

• tapping the button with your finger or stylus,

• using the Tab key on the keyboard to move the highlight from control to
control until the desired control is highlighted, then press the Enter key, or

• holding down the Alt key and pressing the letter in the command button
caption which is underlined. (In the example button, this would be Alt+C).

Activating a command button will cause it to perform the specified function. This may
involve additional dialog boxes or various other modes of interaction with the user.

Frame

A frame groups various controls together into a logical group. Any type of control may
be located within a frame. The only control type that is affected by being in a frame is
the radio button.

Radio Button
Radio buttons are used to select options. They are called radio buttons because they
behave like the selector buttons on a car radio – only one of the buttons in a group
may be selected at a time.

A button may be selected using the following methods:
• positioning the pointing device over the desired button and clicking one time,
• tapping the radio button with your finger or stylus, or
• by using the Tab key to select a set of buttons and then using the up and
down arrow keys ( ) to move from one button in the group to another.

A selected button has a dot in the button and an unselected button has no dot. For
example:

– Selected

– Unselected

Figure 3-2

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CAPINTEC, INC. CAPTUS® 4000e

Check Box
Check boxes are also used to select or enable various options; however, check
boxes work as individual controls not in groups. When a check box is true a “√” will
appear in the box.

A check box may be selected in the following ways:
• positioning the pointing device over the desired check box – clicking one time
will activate the box, clicking again will deactivate the box,
• tapping the check box with your finger or stylus – tapping one time will activate
the box, tapping again will deactivate the box,
• by using the Tab key to select a box and then using the Space Bar to activate
or deactivate the box,
• positioning the pointing device over the desired line and double-clicking will
activate the box, double-clicking again will deactivate the box, or
• double-tapping quickly with your finger or stylus will toggle by the desired item.

A selected box has a check in the box and an unselected box is unchecked. For
example:

– Selected

– Unselected

Figure 3-3

Text Entry Box
The text box is used whenever input of numeric or alphanumeric information is
required.

A text box can be selected in the following ways:
• positioning the pointing device over the box and clicking the pointing device's
left button once,
• tapping the box with your finger or stylus, or
• using the Tab key on the keyboard to move from control to control until the
desired text box is highlighted or the cursor appears in the text box.

When the information in a box is highlighted, typing will replace the highlighted
information and the previous contents will be lost. If you wish to edit the existing
information, use either the left or right arrow ( or ) to move the cursor to the
appropriate location. As soon as the cursor moves, the highlight will be removed. The
contents of the text box can then be edited. The following control keys are active
during editing:

Delete ....................... Deletes the character after the cursor
Backspace ................ Deletes the character before the cursor
Right Arrow ............... Moves one character to the right

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CAPINTEC, INC. CAPTUS® 4000e

Left Arrow.................. Moves one character to the left
End ........................... Moves to the end of the input
Home ........................ Moves to the beginning of the input

Some text input boxes provide input verification. If the information typed in the box is
invalid, i.e. does not match the requested format (for example, an input in a box
requesting a date of 13/45/92) or falls outside the range of valid values, a warning
message will be given and the user will be forced to edit or re-input the information.

When the information in a text box is shaded, it indicates that the data is provided by
the system and cannot be edited by the user.

There is one special type of text box that is used in the CAPTUS® 4000e for input of
comments that will appear on test reports. In these boxes, up to 8,000 characters of
text may be entered. Within the box, text will automatically wrap from one line to the
next as it is typed in. The user may also move to the next line by using the Enter key.
Ctrl+Tab causes a tab to be entered into the text and the cursor to move to the next
tab position (remember pressing just Tab will move you to the next control).

Scroll Bars

There are two types of scroll bars, horizontal and vertical. They are used to change
the value of some parameter within the program.

When using the pointing device to manipulate a scroll bar, there are a number of
actions that will cause the bar to change. Clicking or tapping the arrow at an end of
the bar will cause the “value” of the scroll bar to change in that direction by an amount
referred to as a small change. Clicking or tapping the bar itself at any location
between the end arrow and the slider will cause the value to change in that direction
by an amount referred to as a large change (usually 8 to 32 times the amount of a
small change). The slider may also be moved by placing the pointing device’s cursor
on the slider, pressing the left pointer button down and holding it there while the slider
is “dragged” to the desired position. This can also be accomplished by tapping and
holding the slider with your finger or stylus and “dragging”.

The scroll bar may also be adjusted from the keyboard. The scroll bar is activated
through the Tab key. When it is active the slider will blink. The slider can then be
positioned using the following keys:

Up Arrow ................... Moves the slider a small change up or to the right
Right Arrow ............... Moves the slider a small change to the right or up
Down Arrow............... Moves the slider a small change down or to the left
Left Arrow.................. Moves the slider a small change to the left or down
Home ........................ Moves the slider all the way to the left or down
End ........................... Moves the slider all the way to the right or up

August 15 GENERAL OPERATING INSTRUCTIONS 3-5

CAPINTEC, INC. CAPTUS® 4000e

Spin Control
The spin control is also used to adjust values. The control consists of two back to
back arrows. Clicking an arrow with the pointing device causes the value under
control to change in the specified direction. The spin button can only be controlled
with the pointing device, your finger or stylus.

List Controls
There are two types of “list” controls used in the CAPTUS® 4000e. Both appear quite
similar on the screen (refer to bottom of Figure 3-1). The only difference in
appearance is that on the Drop-Down Combo control, the arrow is not attached to text
box portion, while on the Drop-Down List control the arrow is attached. In function
both controls are similar except for one item. On the Drop-Down Combo control the
user can either enter new data directly into the text box or select from the list. In the
Drop-Down List control the user can only select from the list.

To select an entry from the list, use the pointing device left button to click the down
arrow or tap the down arrow with your finger or stylus. The list will appear. If there are
more items on the list than can be shown, vertical scroll bars will appear on the right
edge of the list. Place the pointer over the desired entry and double-click the left
pointing device button or tap the desired entry with your finger or stylus. The box will
retract and only the selected item will be displayed.

Menu Bars
Across the top of many forms you will find a menu bar. In the example, the menu bar
in Figure 3-1 contains two items: File and Setup. These are referred to as the top-
level menu items. A menu item can be selected either with the pointing device or by
typing Alt+K where K is the letter underlined in the name of the menu item. In some
cases, the top-level menu item causes action to be taken immediately. In other cases,
selecting it will cause another dialog box or menu to appear.

Buttons
Buttons are graphic symbols located on the user module test screens (refer to Figure
3-4 and Figure 3-6). The buttons that are in color are active or enabled and therefore
are selectable. The buttons that are grayed are inactive or disabled and therefore not
selectable.

3-6 GENERAL OPERATING INSTRUCTIONS August 15

CAPINTEC, INC. CAPTUS® 4000e

Figure 3-4

A button can be activated in the following ways:
• positioning the pointing device over the button and clicking the pointing
device's left button once,
• tapping the button with your finger or stylus, or
• using the Tab key on the keyboard to move the highlight from button to button
until the desired control is highlighted and then press the Enter key.

Activating a button causes it to perform the specified function. This may involve
additional dialog boxes or various other modes of interaction with the user.

Keyboard Control
Most commands or actions can also be activated by keyboard strokes. The command
buttons and menu bar items are all controlled from the keyboard in the same manner.
Each word has one letter underlined. Holding down the Alt key, and then pressing the
underlined letter on the keyboard activates the selection. Almost every action in the
CAPTUS® 4000e can be accomplished from keyboard control in this manner.

CAPTUS SCREENS
The CAPTUS® 4000e Main screen appears as shown in Figure 3-5. This screen provides
access to all the user modules (Quality Assurance, Thyroid Uptake, Lab Tests, Wipe Test,
Bioassay, Time Activity Analysis, MCA). At the bottom of the screen, access is provided to
General Setup modules (Setup), an Isotope Reference Library (Isotopes), Archived results
(Archives) and contact information for Capintec, Inc. (About). To select a module, move the
pointing device’s cursor over the name of the module you wish to select. A highlight box will
appear around the module title. Then, single left-click to activate the module. A module can
also be selected by tapping the name of the module you wish to select with your finger or
stylus.

Note: The Custom Protocol and Absorbed Dose ALERT selections shown below are
optional modules and must be purchased separately in addition to the CAPTUS®
4000e system. The related button will be displayed on the Main screen after a valid
license is entered for each module in Setup.

August 15 GENERAL OPERATING INSTRUCTIONS 3-7

CAPINTEC, INC. CAPTUS® 4000e

Figure 3-5

3-8 GENERAL OPERATING INSTRUCTIONS August 15

CAPINTEC, INC. CAPTUS® 4000e
Typical Test Screen
Patient Selected Patient
Buttons Directory Box (Highlighted)
(List of records
in the database)

Check
Box

Command Box Showing Command
Button (Currently Highlighted Button (Currently
Patient’s Status
Inaccessible/ Accessible/
Disabled) Figure 3-6 Enabled)

August 15 GENERAL OPERATING INSTRUCTIONS 3-9

CAPINTEC, INC. CAPTUS® 4000e
Typical Input Screen
Frame around a
Text Entry Box group of Radio

Text Entry Box Buttons
for Comments
Current selection

Command Button: Command Button: Command Button:
Discard Changes Save Changes Add More Wipe
Made and Exit Locations
Made and Exit
Figure 3-7

3-10 GENERAL OPERATING INSTRUCTIONS August 15

CAPINTEC, INC. CAPTUS® 4000e

Measurement Screen

The Measurement screen is identical in all the test procedures and is as shown in Figure 3-8.
The live time elapsed while counting appears on the upper right hand corner of the screen.
The spectrum of the measurement is displayed in the white box.

Figure 3-8

The counting lasts for a duration as specified on the Test Setup screen.

To interrupt the counting, three options are available:

• Re-Measure button or press Alt+R – To discard collected counts and begin counting
again.

• Stop and Save button or press Alt+S – To stop collecting counts midway and save
the data.

• Cancel button or press Alt+C – To stop collecting counts midway and discard the
data collected.

August 15 GENERAL OPERATING INSTRUCTIONS 3-11

CAPINTEC, INC. CAPTUS® 4000e

Add Comments Screen

The screen for adding comments to reports is identical to those for all the test procedures.
You may type in the comments as free text using standard editing keys.

Figure 3-9

The following options are available on this screen:
• Insert File button or press Alt+I – To copy comments from an existing text file (.txt
files only).
• Save to File button or press Alt+S – To save the entered comments as a text file (.txt
file only).
• Cancel button or press Alt+C – To discard the changes made and quit.
• Done button or press Alt+D – To save the changes made and quit.

3-12 GENERAL OPERATING INSTRUCTIONS August 15

CAPINTEC, INC. CAPTUS® 4000e

SHORTCUT KEYS
All Screens

Operation Key(s)

Cycle through all items on the screen Tab
Select from a list of records in the database
Scroll up or down the list of records in the database First letter of the desired record
Move up or down in the list of records in the database (Name field), when the records
Select a function or command box is active
Exit to the previous screen
Page Up and Page Down, when
the records box is active

 and , when the records box is
active

ALT + Underlined letter
OR
Tab(s) and Enter

Esc

Input Screens

Operation Key(s)

Cycle through fields on the screen Tab

Select from a drop-down list First letter of the desired
selection, when drop-down box is
Select within a group of mutually exclusive options active
Choose a Command (e.g. Cancel, Done, New in Figure
3-7 above)  and , when group is active
Cancel changes made and exit to the previous screen
ALT + Underlined letter
OR
Tab(s) and Enter

Esc

August 15 GENERAL OPERATING INSTRUCTIONS 3-13

CAPINTEC, INC. CAPTUS® 4000e

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CAPINTEC, INC. CAPTUS® 4000e

CHAPTER 4

GENERAL SETUP

INSTALLATION ..............................................................................................4-1
ENVIRONMENT REQUIREMENTS .................................................................4-3

Operational .................................................................................................4-3
Storage........................................................................................................4-3
POWER REQUIREMENTS..............................................................................4-4
Input Power.................................................................................................4-4
Isolation Transformer Output ....................................................................4-4
TURN ON PROCEDURE.................................................................................4-4
LOG ON ..........................................................................................................4-5
Sign In .........................................................................................................4-6
Sign Off .......................................................................................................4-6
Admin Log On.............................................................................................4-6
User Log On................................................................................................4-7
Add User.........................................................................................................4-8
Add User – Staff Member...........................................................................4-8
Add User – Not a Staff Member .................................................................4-9
Change Password.........................................................................................4-10
LOG ON REPORT..........................................................................................4-11
Displaying Selected User..........................................................................4-12
Delete User ................................................................................................4-12
Invalidate User...........................................................................................4-13
Revalidate User .........................................................................................4-13
Displaying Data by Date............................................................................4-13
Printing Report ..........................................................................................4-13
Exiting ........................................................................................................4-14
FIRST TIME STARTUP ..................................................................................4-14
System Parameters ...................................................................................4-15
Quality Assurance Tests...........................................................................4-16
Measurement Setups ................................................................................4-17
NORMAL STARTUP ......................................................................................4-18

INSTALLATION
CAUTION: Be sure the instrument has reached room temperature prior to opening
the box. (Leave the box in the room 24 hours before opening it.)

Initial installation and checkout procedures are described in this section. Your system has
been shipped from the factory pre-configured and fully tested. Refer to the included
"UNPACKING AND ASSEMBLY INSTRUCTIONS" document for more details.

November 16 GENERAL SETUP 4-1

CAPINTEC, INC. CAPTUS® 4000e

If your system includes a Floor Stand, installation consists of placing the components on the
Stand and securing them in place as shown in Figure 4-1.

All-in-one Collimator with
Touch Screen Probe Detector
Computer

Keyboard

Pointer

Printer

Well Counter
(Optional)

CAP-MCA
(under shelf)

Floor Isolation
Stand Transformer

Figure 4-1 Complete Assembly with Floor Stand

If your system includes a Table Top Stand, installation consists of placing the components on
a sturdy table or bench.

CAUTION: Only the included USB devices should be connected to the USB ports on

the Computer. If any USB devices other than the models supplied by
Capintec are used, the safety of the unit may be compromised or other
devices located in the same general area as the CAPTUS® 4000e may

become susceptible to EMI. The maximum Input/Output voltages are
5Vdc.

CAUTION: Do not attach a Monitor to the VGA port on the rear of the Computer. If a

Monitor is attached to this port, the safety of the unit may be

compromised or other devices located in the same general area as the
CAPTUS® 4000e may become susceptible to EMI.

4-2 GENERAL SETUP November 16

CAPINTEC, INC. CAPTUS® 4000e

CAUTION: Do not connect the CAPTUS® 4000e to a network. If the system is

attached to a network, the safety of the unit may be compromised or
other devices located in the same general area as the CAPTUS® 4000e

may become susceptible to EMI.

Note: If the system includes the optional Well Counter, please verify that a Well Liner has
been inserted into the Well before use (refer to Figure 4-2 Well Counter Assembly).
This prevents contamination of the Well Detector if a spill or leak occurs.

Plug
Liner
Top Shield

Top Pipe Shield

Base Assembly

Figure 4-2 Well Counter Assembly

ENVIRONMENT REQUIREMENTS
Operational

The instrument should be located where the level of the background radiation is as low and
as constant as possible.

The instrument should be located where the temperature is stable within a range of +50°F to
+85°F (+10°C to +30°C) and the maximum relative humidity is 90% non-condensing to
warrant maximum reliability and accuracy.

The instrument should be located where the barometric pressure is within a range of 27–31
inches of mercury (91–105 kilopascals).

Storage

The instrument should be stored where the temperature is stable and the range is from
+39°F to +110°F (+4°C to +43°C) and the maximum relative humidity is 90% non-condensing
to warrant maximum reliability.

November 16 GENERAL SETUP 4-3

CAPINTEC, INC. CAPTUS® 4000e

The instrument should be stored where the barometric pressure is within a range of 15–33
inches of mercury (51–112 kilopascals).

CAUTION: If these environmental requirements are not followed, the instrument may
display erroneous readings.

POWER REQUIREMENTS
CAUTION: If the input voltage is not within the stated limits, the unit may not
function correctly or may be damaged.

Input Power
Line Voltage: .............115 or 230 Vac depending on model ordered
Line Frequency:.........60 or 50 Hz
Current: .....................2.6 Ampere @ 115V
1.1 Ampere @ 230V
Fuse: For 115V use T 3.15AH, 250V, (Time Delay)
For 230V use T 2.5AH, 250V, (Time Delay)

Isolation Transformer Output
Computer and Monitor combined
Output Voltage:......... 115Vac
Current Output: ......... 2.9A
Frequency:................ 50/60Hz

Printer
Output Voltage:......... 115Vac
Current Output: ......... 0.7A
Frequency:................ 50/60Hz

CAP-MCA
Output Voltage:......... +5Vdc
Current Output: ......... 3.0A

TURN ON PROCEDURE
Verify all system components are mounted securely and all cables are connected. Connect
the Isolation Transformer main power cable to a medical grade wall socket.

All software necessary for proper operation of your CAPTUS® 4000e Thyroid Uptake System
has been pre-installed and tested at the factory to ensure trouble-free setup.

4-4 GENERAL SETUP November 16

CAPINTEC, INC. CAPTUS® 4000e

Note: To remove main power from the system, the Isolation Transformer main power cable
must be unplugged from the wall socket.

There are three power switches associated with the system:
• the computer has a power switch, and
• the CAP-MCA has a power switch,
• the printer has a power switch.

Turn on all three switches.

Your system will power up, go through the computer boot-up sequence, and display the
Windows® start up screen.

CAUTION: Changing the date or time while a timed test is in progress (for example,
a 24 hour Thyroid Uptake Test) might affect the results or introduce
unexpected error. Care should be taken to evaluate any potential impact
for ongoing tests before changing the date or time. Verify that the under
the Date and Time Properties in Windows that the Automatically adjust
clock for daylight saving changes checkbox is not checked.

LOG ON
Note: Before performing any measurements, allow the system to warm up at least 30

minutes.

To run the CAPTUS® 4000e software, double-click on the CAPTUS® 4000e icon. When the
program is launched, Figure 4-3 Log On Sign In Window will appear:

November 16 Figure 4-3 Log On Sign In Window 4-5

GENERAL SETUP

CAPINTEC, INC. CAPTUS® 4000e

Sign In
Users must set up by the Administrator prior to logging on to the CAPTUS® 4000e. User
Names and Passwords are case sensitive.

Input the User Name and then the Password. Asterisks (*) will appear when the Password is
entered.

The OK button will be enabled when entries have been made in both User Name and
Password.

When the User Name and Password are correct, selecting the OK button will exit the Sign
On screen and Figure 4-13 Main Screen will appear.

Note: If the Startup Tips option is enabled, Figure 4-10 Startup Tips Window
will appear instead of Figure 4-13 Main Screen.

Sign Off
After signing in to the CAPTUS® 4000e, a user may sign off by selecting the Sign Off button
(Refer to Figure 4-13 Main Screen). Selecting this button will end the session for the
currently logged on user and display Figure 4-3 Log On Sign In Window so that another user
can sign on.

Admin Log On
The Administrator is the user who has control of user management. The Administrator can
view and print Log On / Log Off Reports and can add, delete or invalidate users.

For the Administrator to log on:
• In the User Name text box, input Admin and press the Tab key.
• In the Password text box, input the password (AlphaDrive is default) and press the
Tab key.

Note: User Names and Passwords are case sensitive.

Note: It is recommended that the Admin password be changed at first log in.

4-6 GENERAL SETUP November 16


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